Basic Institutional Review Board (IRB) Test Questions and Answers – Latest 2023/2024 (Verified Answers) 100% Correct

Basic Institutional Review Board (IRB) Test Questions and Answers – Latest 2023/2024 (Verified Answers) 100% Correct A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Report the adverse drug experience in a timely manner, in keeping with the IRB’s policies and procedures, using the forms or the mechanism provided by the IRB. The most appropriate action for the investigator to take is to report the adverse drug experience in a timely manner using the forms provided by the institution. How long is an investigator required to keep consent documents, IRB correspondence, and research records? For a minimum of three years after completion of the study Research investigators are responsible for retaining signed consent documents, IRB correspondence, and research records for at least three years after completion of the research. Because research records are the property of the institution, local institutional policy or sponsoring agency requirements may dictate these records are kept longer. The sponsor and the IRB office should be contacted to make sure that the minimum of three years meets their requirements. According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations. Expedited review procedures are appropriate only for protocols that present no greater than “minimal